Objectives: Although the relationship between migraine and cardiovascular disease (CVD) has been studied, several questions remain unanswered. Herein we contrast the rate of diagnosed CVD as well as of risk factors for CVD in individuals with migraine with and without aura (MA and MO) and in controls. Methods:In this case-control study, migraineurs (n ϭ 6,102) and controls (n ϭ 5,243) were representative of the adult US population. Headache diagnosis was formally assigned using a validated mailed questionnaire which also obtained details on treatment, comorbidities, and other variables. CVD events were obtained based on self-reported medical diagnosis. Risk factors for CVD and modified Framingham scores were computed. Results:In unadjusted analyses, migraine overall and MA were associated with myocardial infarction, stroke, and claudication, and MO was associated with myocardial infarction and claudication. Migraineurs were more likely than controls to have a medical diagnosis of diabetes (12.6% vs 9.4%, odds ratio [OR] 1.4, 95% confidence interval [CI] 1.2-1.6), hypertension (33.1% vs 27.5%, OR 1.4, 95% CI 1.3-1.6), and high cholesterol (32.7% vs 25.6%, OR 1.4, 95% CI 1.3-1.5). Risk was highest in MA, but remained elevated in MO. Framingham scores were significantly higher in MO and MA than in controls. After adjustments (gender, age, disability, treatment, CVD risk factors), migraine remained significantly associated with myocardial infarction (OR 2.2, 95% CI 1.7-2.8), stroke (OR 1.5, 95% CI 1.2-2.1), and claudication (OR 2.69, 95% CI 1.98 -3.23). Conclusion:Both migraine with and without aura are associated with cardiovascular disease (CVD) and with risk factors for CVD. However, since our sample size is large, the clinical relevance of the differences is yet to be established. Neurology ® 2010;74:628 -635

ABSTRACT. Background. The greatest prevalence of asthma is in preschool children; however, the clinical utility of asthma therapy for this age group is limited by a narrow therapeutic index, long-term tolerability, and frequency and/or difficulty of administration. Inhaled corticosteroids and inhaled cromolyn are the most commonly prescribed controller therapies for young children with persistent asthma, although very young patients may have difficulty using inhalers, and dose delivery can be variable. Moreover, reduced compliance with inhaled therapy relative to orally administered therapy has been reported. One potential advantage of montelukast is the ease of administering a once-daily chewable tablet; additionally, no tachyphylaxis or change in the safety profile has been evidenced after up to 140 and 80 weeks of montelukast therapy in adults and pediatric patients aged 6 to 14 years, respectively.To our knowledge, this represents the first large, multicenter study to address the effects of a leukotriene receptor antagonist in children younger than 5 years of age with persistent asthma, as well as one of the few asthma studies that incorporated end points validated for use in preschool children.Objective. Our primary objective was to determine the safety profile of montelukast, an oral leukotriene receptor antagonist, in preschool children with persistent asthma. Secondarily, the effect of montelukast on exploratory measures of asthma control was also studied.Design and Statistical Analysis. We conducted a double-blind, multicenter, multinational study at 93 centers worldwide: including 56 in the United States, and 21 in countries in Africa, Australia, Europe, North America, and South America. In this study, we randomly assigned 689 patients (aged 2-5 years) to 12 weeks of treatment with placebo (228 patients) or 4 mg of montelukast as a chewable tablet (461 patients) after a 2-week placebo baseline period. Patients had a history of physician-diagnosed asthma requiring use of ␤-agonist and a predefined level of daytime asthma symptoms. Caregivers answered questions twice daily on a validated, asthmaspecific diary card and, at specified times during the study, completed a validated asthma-specific quality-oflife questionnaire. Physicians and caregivers completed a global evaluation of asthma control at the end of the study.Efficacy end points included: daytime and overnight asthma symptoms, daily use of ␤-agonist, days without asthma, frequency of asthma attacks, number of patients discontinued because of asthma, need for rescue medication, physician and caregiver global evaluations of change, asthma-specific caregiver quality of life, and peripheral blood eosinophil counts. Although exploratory, the efficacy end points were predefined and their analyses were written in a data analysis plan before study unblinding. At screening and at study completion, a complete physical examination was performed. Routine laboratory tests were drawn at screening and weeks 6 and 12, and submitted to a central laboratory for a...

In this study, the perceptions of asthmatics to change in their disease was associated with observed changes in clinical asthma measures, in order to identify the threshold where changes in clinical asthma measures are perceivable by patients.The study included 281 asthmatic patients, aged 18±63 yrs, in a randomized, placebo-controlled clinical trial of a leukotriene antagonist. Changes were related in: 1) asthma symptom scores; 2) inhaled b-agonist use; 3) forced expiratory volume in one second (FEV1); and 4) peak expiratory flow (PEF) to a global question that queried overall change in asthma since starting the study drug. Additional analyses examined differences in the group reporting minimal improvement by treatment (active treatment versus placebo), sex and age groups.The average minimal patient perceivable improvement for each measure was: 1) -0.31 points for the symptom score on a scale of 0±6; 2) -0.81 puffs . day -1 for inhaled bagonist use; 3) 0.23 L for FEV1; and 4) 18.79 L . min -1 for PEF. In general placebotreated patients and older patients, who reported minimal improvement, experienced less mean improvement from baseline than active-treated patients and younger patients, who reported minimal improvement.Determining the minimal patient perceivable improvement value for a measure may be helpful to interpret changes. However, interpretation should be carried out cautiously when reporting a single value as a clinically important change. Eur Respir J 1999; 14: 23±27. Asthma is a chronic respiratory disease characterized histologically by airway inflammation and mucus hypersecretion, and clinically by reversible airway obstruction and specific patient-reported symptoms [1]. In clinical trials, changes in asthma are measured by pulmonary function tests, such as forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF), as well as by b-agonist inhaler use, and validated symptom scales that capture patient-reported symptoms [2]. While a clinical trial can be powered to find small differences between treatment groups on any one of these asthma measures, the meaning of these changes is often unknown. The question is often asked: "Do differences in asthma measures noted at the end of the study matter to the patients, that is are they clinically meaningful?". As an example, is an average of 1 or 2 puffs . day -1 decrease in b-agonist inhaler use or an increase of 8 or 10% in FEV1 perceived by patients?One method of providing clinical meaning is to relate change in one measure to a global measure of patientrated change. For example, JAESCHKE et al.[3] related average changes in scores on a health-related quality-oflife (HRQoL) questionnaire to patients' global ratings of change in their disease within an observational study environment. In this way, they provided meaning to changes in scores from baseline within groups on a newly developed HRQoL questionnaire.In this study, the theoretical framework of JAESCHKE et al. [3] was utilized in order to provide clinical meaning to changes...

Determinants of patient satisfaction with migraine treatment are not well understood. The objective of this study was to evaluate which treatment outcomes influence patient satisfaction with treatment. Analyses were performed on data from 1506 migraineurs from two clinical trials of rizatriptan for treatment of migraine. Satisfaction with treatment was assessed 2 h after initial treatment and prior to use of rescue therapy. Over 90% of patients who were pain-free at 2 h were at least somewhat satisfied with treatment compared with <10% of patients with moderate or severe pain. Only 60-70% of patients with mild pain at 2 h experienced some level of satisfaction with treatment. For patients with mild pain at 2 h, results showed subjects who reported severe pain at baseline, absence of associated symptoms at 2 h and pain relief within the first 90 min had at least a 76% probability of being at least somewhat satisfied. This probability decreased with the presence of associated symptoms, slower pain relief and moderate baseline pain intensity. Fast, complete pain relief is one important factor in determining short-term patient satisfaction with treatment.

The results suggest that cholesterol lowering itself is beneficial but that specific adverse effects of fibrates and hormones increase the risk of CHD (hormones only), non-CHD, and total mortality.